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The Outcomes of Perthes’ Disease of the hip: a study protocol for the development of a Core Outcome Set.

Leo, DG, Leong, WJ, Gambling, T, Long, A, Murphy, RC, Jones, H and Perry, D The Outcomes of Perthes’ Disease of the hip: a study protocol for the development of a Core Outcome Set. Trials. ISSN 1745-6215 (Accepted)

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Abstract

Background Perthes’ disease is an idiopathic osteonecrosis of a developmental hip that is most frequent in Northern Europe. Currently, the absence of a common set of standardized outcomes makes comparisons between studies of different interventions challenging. This study aims to summarise the outcomes used in clinical research of interventions for Perthes’ disease, and define a set of core outcomes (COS) to ensure that the variables of primary importance are measured and reported in future research studies investigating Perthes’ disease. Methods and Analysis A systematic review of the current literature will be used to identify a list of outcomes reported in previous studies. Additional important outcomes will be sought by interviewing a group of children with Perthes’ disease, adults who were treated with the disease in infancy and parents of children with the disease. This list will then be evaluated by experts in Perthes’ disease using a Delphi survey divided into two rounds to ascertain the importance of each outcome. The final outcomes list obtained from the Delphi survey, will be then discussed during a consensus meeting of representative key stakeholders in order to define the COS to be reported in future clinical trials related to Perthes’ disease. Discussion The absence of high-quality research and clear guidelines concerning the management of Perthes’ disease is, at least in part, due to the difficulties in the comparing the results from previous studies. The development of a Core Outcomes Set (COS) seeks to standardise outcomes collected in future research studies to enable comparisons between studies to be made and to facilitate meta-analyses of results. Registration details: The study has been registered with both Core Outcome Measures in Effectiveness Trials Initiative (COMET) and Prospero International Prospective Register of Systematic Reviews. COMET registration number 1003 (20 July 2017). Prospero registration number CRD 42017069742 (10 July 2017).

Item Type: Article
Uncontrolled Keywords: 1102 Cardiovascular Medicine And Haematology, 1103 Clinical Sciences
Subjects: R Medicine > RC Internal medicine > RC1200 Sports Medicine
Divisions: Sport & Exercise Sciences
Publisher: BioMed Central
Date Deposited: 22 May 2018 10:57
Last Modified: 19 Sep 2018 09:11
URI: http://researchonline.ljmu.ac.uk/id/eprint/8697

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